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Local Anesthetic

Lidocaine topical for Cluster Headache

Phase 3
Waitlist Available
Led By Adam Sivitz, MD
Research Sponsored by Newark Beth Israel Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Frontal migraine headache
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 hours from ed registration
Awards & highlights

Study Summary

This trial is comparing two different methods of migraine relief in children aged 10 and up - one involving a nasal sphenopalatine block with lidocaine, and the other prochlorperazine given intravenously.

Eligible Conditions
  • Childhood Migraine
  • Cluster Headache
  • Migraine

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 hours from ed registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 hours from ed registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ED Length of stay
Time to headache resolution
Secondary outcome measures
24 hr follow up
Determine adequacy of blinding
Number of participants with treatment induced side effects
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SPG blockExperimental Treatment1 Intervention
SPG block performed by using qtip applicator soaked in 2% lidocaine and placed posteriorly into nasal cavity where it dwells for up to 30 min
Group II: ControlActive Control1 Intervention
Delivered through IV access obtained in all patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine topical
2018
Completed Phase 4
~320

Find a Location

Who is running the clinical trial?

Newark Beth Israel Medical CenterLead Sponsor
11 Previous Clinical Trials
1,227 Total Patients Enrolled
Adam Sivitz, MDPrincipal InvestigatorNewark Beth Israel Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How often has Lidocaine been studied in the past?

"At the moment, there are 139 clinical trials researching the efficacy of Lidocaine topical. 36 of those trials are in the third and final stage. The majority of these studies are based in Calgary, Alberta; however, there are 1105 locations running these sorts of trials."

Answered by AI

Is Lidocaine topical safe for human use?

"Lidocaine topical scored a 3 for safety. This is due to the fact that it is a Phase 3 trial, which suggests that not only is there some evidence of efficacy, but also that there have been multiple rounds of data collected to support its safety."

Answered by AI

Will this experiment include people who are over the age of 50?

"The age limit for participants in this clinical trial is between 10 and 20 years old."

Answered by AI

How can I sign up for this clinical trial?

"This particular clinical trial is seeking to enrol 72 adolescents between the ages of 10 and 20 who suffer from sphenopalatine neuralgia. In order to be eligible, participants must also meet the following: - Frontal migraine headache."

Answered by AI

Are participants being sought for this research project at this time?

"This is accurate. The clinical trial is admitting 72 participants between 1 sites."

Answered by AI

How many people are taking part in this clinical trial?

"The information available on clinicaltrials.gov supports that this trial is currently looking for participants. This study was first posted on 2019-06-06 and was most recently edited on 2021-11-16. 72 patients need to be enrolled from 1 location."

Answered by AI

What are the main goals of this experiment?

"The purpose of this trial, which will last for up to 6 hours after participants are discharged, is to study the time it takes for headaches to resolve. Additionally, the trial will also monitor for side effects that occur within 24 hours of the intervention, patient satisfaction, and whether or not the headache persists after 24 hours."

Answered by AI

Lidocaine topical is most commonly applied to which medical conditions?

"Lidocaine topical is most frequently used as a treatment for cervical syndrome. However, it has also been shown to ameliorate symptoms related to minor burns, transplantation, and osteoporosis."

Answered by AI
~12 spots leftby Apr 2025